Valvular & structural heart diseaseRandomised controlled trial
Transcatheter Closure of Patent Foramen Ovale With a Novel Biodegradable Device: A Prospective, Multicenter, Randomized Controlled Clinical Trial
- Randomised controlled trial
- multicentre
- non-inferiority
Authors' conclusion
The novel biodegradable PFO closure device, which disappears on echocardiography within 24 months after implantation, demonstrates noninferiority to the traditional nitinol device in both efficacy and safety.
Study context
- Population
- Patients with patent foramen ovale (PFO)
- Participants
- 190 patients
- Comparison
- Biodegradable PFO closure device vs nitinol device
- Biodegradable devicen = 96
- Nitinol devicen = 94reference
- Primary endpoint
- PFO closure success rate by contrast echocardiography
- Follow-up
- 6 months postprocedure
Primary result
As reported in the abstract
PFO closure success · 6 months
lower limit of CI −8.98%
Further findings
events
| Outcome | Biodegradable device | Nitinol device |
|---|---|---|
| Death, embolism, device thrombus or erosion · entire study period | 0 | 0 |
Device disappearance on transthoracic echocardiography (biodegradable device) · 24 months
- Hyperechoic area began decreasing within the first year and disappeared on echocardiography by 24 months
Safety
Surgical device removal (intraprocedural deformation)
- Patients in the trial (biodegradable) group requiring surgical device removal because of intraprocedural deformation
- 1
Original publication
Transcatheter Closure of Patent Foramen Ovale With a Novel Biodegradable Device: A Prospective, Multicenter, Randomized Controlled Clinical Trial. Circulation. Published 13 October 2025. doi:10.1161/circulationaha.125.074609
Summarised from the published abstract; every number is checked against it